Tailored Anti-Inflammatory (A-I) Diet for Americans With Ulcerative Colitis (UC)

NCT ID: NCT06784323

Last Updated: 2025-12-11

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 122 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-05
• Study Completion Date: 2030-09-01

Brief Summary

The purpose of this study is to test the effect of an anti-inflammatory diet that incorporates native foods of the American diet on disease remission in American patients with Ulcerative Colitis (UC) and to identify biomarkers of response to dietary therapy.

Conditions

Ulcerative Colitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Catered diet group

Participants will be in this arm for up to 8 weeks.

Group Type: EXPERIMENTAL

Catered diet

Intervention Type: BEHAVIORAL

For a period of 8 weeks the participant will receive catered food, the study team will provide the participants breakfast, lunch and dinner. Participants will receive catered food for 3 daily meals, and record daily food intake. Catered diet will be sent to participants' homes on a weekly basis. The diet will consist of primarily whole foods with few additives, with a focus on American staple foods.

Diet guidance sessions

Intervention Type: BEHAVIORAL

Participants will receive virtual weekly diet guidance with a dietitian regarding food safety preparation methods and cooking practices. Patients will receive weekly gift cards for grocery stipend. On average, initial counseling session with dietitian will last 30 minutes, and 7 follow-up sessions will last 20 minutes.

Dietary counseling

Intervention Type: BEHAVIORAL

Participants will receive dietary counseling weekly on Zoom for up to 30 minutes. Dietitian will meet with participants to explain benefits of adhering to diet therapy.

Feedback sessions

Intervention Type: BEHAVIORAL

Participants will be involved in one-time 50-minute feedback session over Zoom with dietitian and principal investigator. During the session, participants will discuss preferred foods/recipes during active disease, likeability of recipes, ease of recipe preparation, dietary adherence, and healthy food affordability.

Diet guidance sessions group

Participants will be in this arm for up to 8 weeks.

Group Type: EXPERIMENTAL

Catered diet

Intervention Type: BEHAVIORAL

For a period of 8 weeks the participant will receive catered food, the study team will provide the participants breakfast, lunch and dinner. Participants will receive catered food for 3 daily meals, and record daily food intake. Catered diet will be sent to participants' homes on a weekly basis. The diet will consist of primarily whole foods with few additives, with a focus on American staple foods.

Diet guidance sessions

Intervention Type: BEHAVIORAL

Participants will receive virtual weekly diet guidance with a dietitian regarding food safety preparation methods and cooking practices. Patients will receive weekly gift cards for grocery stipend. On average, initial counseling session with dietitian will last 30 minutes, and 7 follow-up sessions will last 20 minutes.

Dietary counseling

Intervention Type: BEHAVIORAL

Participants will receive dietary counseling weekly on Zoom for up to 30 minutes. Dietitian will meet with participants to explain benefits of adhering to diet therapy.

Feedback sessions

Intervention Type: BEHAVIORAL

Participants will be involved in one-time 50-minute feedback session over Zoom with dietitian and principal investigator. During the session, participants will discuss preferred foods/recipes during active disease, likeability of recipes, ease of recipe preparation, dietary adherence, and healthy food affordability.

Interventions

Catered diet

For a period of 8 weeks the participant will receive catered food, the study team will provide the participants breakfast, lunch and dinner. Participants will receive catered food for 3 daily meals, and record daily food intake. Catered diet will be sent to participants' homes on a weekly basis. The diet will consist of primarily whole foods with few additives, with a focus on American staple foods.

Intervention Type: BEHAVIORAL

Diet guidance sessions

Participants will receive virtual weekly diet guidance with a dietitian regarding food safety preparation methods and cooking practices. Patients will receive weekly gift cards for grocery stipend. On average, initial counseling session with dietitian will last 30 minutes, and 7 follow-up sessions will last 20 minutes.

Intervention Type: BEHAVIORAL

Dietary counseling

Participants will receive dietary counseling weekly on Zoom for up to 30 minutes. Dietitian will meet with participants to explain benefits of adhering to diet therapy.

Intervention Type: BEHAVIORAL

Feedback sessions

Participants will be involved in one-time 50-minute feedback session over Zoom with dietitian and principal investigator. During the session, participants will discuss preferred foods/recipes during active disease, likeability of recipes, ease of recipe preparation, dietary adherence, and healthy food affordability.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Documented diagnosis with ulcerative colitis from medical records.
• Self-Identify as American
• Ages 16-75
• SCCAI between 3-9 (no greater than 12 bowel movements a day)
• Fecal calprotectin > 150mg/dl.
• On stable medications for their disease for the past 3 months
• Likeability of American foods (sandwiches, BBQ or grilled meats and vegetables, baked potatoes, smoothies, salmon, oatmeal, avocado, soups)
• No recent Inflammatory Bowel Disease (IBD) related hospitalization in the last month.

Exclusion Criteria

• Diagnosis of Crohn's Disease (CD).
• Prior ileoanal anastomosis (J-pouch) or diversion
• No recent hospitalizations on the last 4 weeks
• No Clostridium difficile or enteric infections on the last 4 weeks
• No use of probiotics on the last 4 weeks
• Patients following the specific carbohydrate diet or mediterranean diet or anti-inflammatory diet
• No active cancer or conditions limiting their ability to follow a diet (heart failure, end stage renal disease)
• Pregnancy, breastfeeding or planning to become pregnant during study period
• Use of Total Parenteral Nutrition at the time of screening and during the study period
• Other significant or life-threatening co-morbidities
• The need for antibiotic use during the study period
• Adults unable to consent
• Ages less than 16 and > 75 years old
• Prisoners

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role: collaborator

University of Miami

OTHER

Sponsor Role: lead

Responsible Party

Oriana Mazorra Damas

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Oriana Damas, MD, MSCTI

Role: PRINCIPAL_INVESTIGATOR

University of Miami Health System

Locations

University of Miami Health System

Miami, Florida, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Oriana Damas, MD, MSCTI

Role: CONTACT

omazorra@med.miami.edu

305 243-6405

Eytan I Stern, MS, RD, LD/N, CNSC

Role: CONTACT

eis43@miami.edu

305 243-6405

Facility Contacts

Niurka Colina, CRC

Role: primary

nxc610@miami.edu

305 243-6405

Michael Mijares

Role: backup

mmijares74@med.miami.edu

305 243-6405

Other Identifiers

1R01DK140964-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

20240857

Identifier Type: -

Identifier Source: org_study_id